NCT04644432

Individualized Treatment Strategy for Patients With Metastatic Non-clear Cell Renal Cell Carcinoma

A Phase II Study of an Individualized Treatment Strategy for Patients With Metastatic Non-clear Cell Renal Cell Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Herlev and Gentofte Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the open-label INDIGO-study is to examine whether a first line individualized treatment strategy based on DNA and RNA analyses from the patient's tumor is feasible. Moreover, to involve the patient further in their treatment via patient-reported outcomes (PRO) measurements in a value-based healthcare setup with simultaneous analyses of the financial costs of this strategy. The patients are assigned into 4 treatment arms according to the results of their DNA and RNA analyses. All patients receive electronic questionnaires regarding symptoms and side effects weekly and questionnaires regarding quality of life monthly. Based on each patient's answers of the questionnaires the patient receives advices in the app to reduce the symptoms and side effects or the patient is instructed to contact the hospital. The hypothesis: Basing the choice of first-line treatment for DNA mutations and RNA profiles in a heterogeneous patient population increases the overall response rate for the total population to 30% compared to 10% for historical cohorts.

Conditions

• Metastatic Renal Cell Carcinoma
• Kidney Neoplasm
• Urologic Neoplasms
• Urogenital Neoplasms

Interventions

Type	Name	Description
DRUG	Medication (A specification is listed under each arm)	Study drugs and dosages are listed in the description of arms.
OTHER	Patient reported outcomes measurement	PRO questionnaires regarding symptoms and side effects with questions selected from the Nation Cancer Institute Patient Reported Outcomes-Common Terminology Criteria for Adverse Events. The patient receive individual advices according to the patient's answers to reduce the symptoms and side effects or is instructed to contact the hospital. For monitoring quality of life the EORTC QLQ-C30 is used. All questionnaires are in Danish.

Timeline

• Start date: 2020-03-06
• Primary completion: 2022-09-06
• Completion: 2022-09-06
• First posted: 2020-11-25
• Last updated: 2020-11-25

Locations

1 site across 1 country: Denmark